Evolutionary Systems Therapy for Personality Pathology (ESTP)

Evolutionary Systems Therapy for Early Onset of Personality Pathology: A Pilot Study on the Effectiveness and Feasibility With Adolescents and Young Adults

Evolutionary Systems Therapy is a new form of therapy that has been previously tested in a randomized controlled trial and in a few cases of patients diagnosed with Cluster A personality disorders. The objective of the present study is to investigate the feasibility and preliminary efficacy of Evolutionary Systems Therapy in all forms of personality disorders. The study includes three project actions: (i) a case series on adolescents with personality disorders; (ii) a case series on young adults with personality disorders; (iii) an ecological momentary assessment study to confirm the conceptualization model on all the patients.

Study Overview

• Status: Recruiting
• Conditions: Personality Disorders
• Intervention / Treatment: Behavioral: Evolutionary Systems Therapy

Detailed Description

To explore the feasibility and preliminary efficacy of Evolutionary Systems Therapy, the present study includes three actions. In the first action investigators enroll 6 adolescents (16-19 years) with personality disorders, in the second 15 young adults (20-25 years) with personality disorders. All participants receive 6 months of psychotherapy. The two subsamples of patients (adolescents and young adults) are assessed based on the conceptualization model of Evolutionary Systems Therapy which envisages three macro-organizations of personality (consistently with dimensional and hierarchical models such as Hierarchical Taxonomy of Psychopathology): internalizing, externalizing, schizotypal. Investigators plan to recruit patients until the size of the sub-samples is reached (15 young adults divided into 3 groups of 5 patients, each for each of the three interpersonal patterns; 6 adolescents divided into 3 groups of 2 patients, each for each of the three patterns interpersonal). In the third action, an ecological momentary assessment study will investigate the consistency over time between the conceptualization model and the experiences of the young adult patients enrolled: investigators will explore whether the hypothesized conceptualization will be confirmed by collected data on the patients' interpersonal styles.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessia Saini; Phone Number: +39 055679037; Email: alessia.saini@tagesonlus.org

Study Locations

• Italy
  • FI
    • Firenze, FI, Italy, 50137
      • Recruiting
      • Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
      • Principal Investigator: Simone Cheli, PhD
      • Sub-Investigator: Gil Goldzweig, PhD
      • Contact: Alessia Saini; Phone Number: +39 055 679037; Email: alessia.saini@tagesonlus.org
      • Sub-Investigator: Martin Bruene, MD
      • Sub-Investigator: Veronica Cavalletti, PsyD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being diagnosed with personality pathology in accordance with Structured Clinical Interview for DSM-5 - Alternative Model of Personality Disorders Module I
• Being capable of read and sign the inform consent form

Exclusion Criteria:

• Being diagnosed with schizophrenia spectrum disorders and other psychosis
• Being diagnosed with bipolar disorders
• Being diagnosed with autism spectrum disorder
• Being diagnosed with intellectual disability
• Being under any psychopharmacological or psychosocial treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychotherapy; All the participants receive as active treatment a form of psychotherapy for personality disorders (Evolutionary Systems Therapy). The treatment last 6 months (24 weekly sessions, each lasting 50-60 minutes).	Behavioral: Evolutionary Systems Therapy; Evolutionary Systems Therapy is an individual form of psychotherapy (talk therapy) that has been previously tested trough a randomized controlled trial and a few cases series, confirming its feasibility and safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of individual change in personality pathology over time	At least 75% rate of change in personality pathology over time as defined by a downward trend in mean of total score of Personality Inventory for DSM-5 Brief Form)	9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.
Group change in personality pathology over time	Group change in personality pathology over time as defined by statistically significant change of sample mean of total score of Personality Inventory for DSM-5 Brief Form)	9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.
Feasibility of the intervention	At least 70% rate of completion, adherence, therapeutic alliance and adverse events	6 measurements: at the end of each of the six months of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential effect of the intervention between interpersonal patterns	Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by Personality Inventory for DSM-5 Brief Form	9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.
Specific effect of the intervention between interpersonal patterns	Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by Personality Inventory for DSM-5 Brief Form.	40 measurements: 20 measurements in the month before surgery (2 measurements per day for the 10 days before the start of therapy) and 20 measurements in the month after surgery (2 measurements per day for the 10 days after the end of therapy)
Remission from diagnosis	At least 70% rate of remission from diagnosis of personality pathology	2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)

Collaborators and Investigators

• Sponsor: Tages Onlus
• Investigators: Principal Investigator: Simone Cheli, PhD, Tages Onlus

Publications and helpful links

General Publications

• Cheli, S., Chiarello, F., & Cavalletti, V. (2023). A psychotherapy oriented by compassion and metacognition for schizoid personality disorder: A two cases series. Journal of Contemporary Psychotherapy: On the Cutting Edge of Modern Developments in Psychotherapy, 53(1), 61-70. https://doi.org/10.1007/s10879-022-09566-3
• Cheli, S., Cavalletti, V. An Evolutionarily Oriented Therapy for Autistic Adolescents with Extraordinary Skills: A Two-Case Series. J Contemp Psychother 53, 297-304 (2023). https://doi.org/10.1007/s10879-023-09586-7
• Cheli, S., & Brüne, M. (In press). When do personality traits become pathological? An epistemological and evolutionary view. To appear in Konrad Banicki and Peter Zachar (Eds.), Novel Conceptual Approaches to Personality Disorders for Psychologists and Philosophers. Cambridge University Press.
• Cheli S, Cavalletti V, Lysaker PH, Dimaggio G, Petrocchi N, Chiarello F, Enzo C, Velicogna F, Mancini F, Goldzweig G. A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment. BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5.
• Cheli S, Goldzweig G, Chiarello F, Cavalletti V. Evolutionary systems therapy for paranoid personality disorder: A seven cases series. Bull Menninger Clin. 2024 Winter;88(1):61-80. doi: 10.1521/bumc.2024.88.1.61.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: metacognition; personality disorder; compassion; personality pathology; evolutionary psychopathology
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders
• Other Study ID Numbers: 0124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the data collected as well as the study documents will be available on the Open Science Foundation no later than September 2024
• IPD Sharing Time Frame: May 2024
• IPD Sharing Access Criteria: Open Access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No